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NCT Number: NCT04303390

24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis

A randomized control trial studying the effect of prophylactic antibiotics to reduce surgical site infections following cardiac surgery in adults using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime).

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saud AlBabtain Cardiac Center

Dammam, Eastern Province, 31463, Saudi Arabia

About this study

A prospective randomized controlled patient blinded study with 2x2 factional design. It aims to study optimal duration of antibiotic to reduce surgical site infections following cardiac surgery in adults 24 or 48 hours using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime). Patients shall remain on either medicines for 24 or 48 hours. The primary endpoints of the study are:(1) 48 hours antibiotic prophylaxis is superior to 24 hours in adult cardiac surgery (2) Cefuroxime is superior to Cafazolin as a prophylactic antibiotic in adult cardiac surgery. Secondary endpoints include; organisms causing surgical site infections, length of hospital and ICU stay, and worsening in renal function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide informed consent
  • Planned to undergo a cardiac surgical procedure

Exclusion criteria

  • Patients on antibiotics on the day of surgery or those who received any within 7 days for any reason
  • Patients taken to operating room as salvage
  • Patients who are allergic to either cefuroxime or cefazolin
  • Patients for LVAD or ECMO
  • Patients who are known MRSA carriers
  • Patients receiving steroid therapy

Treatment and study plan

cefuroxime

Drug

second generation cephalosporin

Cefazolin

Drug

First generation cephalosporin

24 hours

Other

Duration of antibiotic therapy

48 hours

Other

Duration of antibiotic therapy

Primary outcomes

  1. surgical site infection rate is less with Cefuroxime than Cefazolin

    Time frame: within 3 months from date of surgery

    that Second Generation Cefalosporin is superior to first generation

  2. surgical site infection rate is less with 48 hours rather than 24 hours

    Time frame: within 3 months from date of surgery

    That Longer duration of prophylaxis is better than shorter duration

Secondary outcomes

  1. Length of actual Hospital Stay in the group assigned to 48 hours of cefuroxime

    Time frame: within 3 months from date of surgery

    that 48 hours of cefuroxime will reduce hospital stay

  2. Length of ICU Stay will be shorter in the group assigned to 48 hours of cefuroxime

    Time frame: within 3 months from date of surgery

    that 48 hours of cefuroxime will reduce ICU stay

  3. rate of infection with a specific organism following each of the antibiotics used

    Time frame: within 3 months from date of surgery

    type of organism following each type of antibiotic used

  4. change from baseline of serum creatinine for each antibiotic used

    Time frame: within 3 months from date of surgery

    that 48 hours of cefuroxime will not worsen renal function

Sponsors and collaborators

Lead sponsor

Saud Al Babtain Cardiac Center

Other Gov

Registry information

Official study title

24 Versus 48 Hours of First Generation or Second Generation Cephalosporin as Prophylaxis to Reduce Surgical Site Infection in Adult Cardiac Surgery Patients: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2020
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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